To Evaluate the Bioavailability of a Tablet of AZD1656

November 2, 2009 updated by: AstraZeneca

A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1

To evaluate the bioavailability of a tablet of AZD1656.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, type I diabetes patients, female with non child-bearing potential.
  • Treated with insulin for more than 3 years. Well controlled HbA1c.
  • Have a body mass index (BMI) ≥19 and ≤35

Exclusion Criteria:

  • Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
  • Daily use of nicotine containing substances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
AZD1656 tablet + food
Drug: AZD1656
Single dose oral tablet
Drug: AZD1656
Single dose oral suspension
Active Comparator: 2
AZD1656 susp. without food
Drug: AZD1656
Single dose oral tablet
Drug: AZD1656
Single dose oral suspension
Active Comparator: 3
AZD1656 tablet
Drug: AZD1656
Single dose oral tablet
Drug: AZD1656
Single dose oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
Time Frame: Blood samples taken up to 72 hours
Blood samples taken up to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic variables (Plasma glucose)
Time Frame: Taken repeatedly during treatment periods
Taken repeatedly during treatment periods
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
Time Frame: Taken during treatment periods
Taken during treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Klas Malmberg, MD, PhD, Prof, AstraZeneca R&D Mölndal
  • Principal Investigator: Emanuel P DeNoia, MD, Healthcare Discoveries LLC Icon Development Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 24, 2008

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

November 3, 2009

Last Update Submitted That Met QC Criteria

November 2, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1020C00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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